Asia-Pacific Roundup: Korean Pharmacopoeia selected to participate in Pharmacopeial Discussion Group

The Korean Pharmacopoeia has been chosen as the next organization to start the process of joining the Pharmacopeial Discussion Group (PDG).

PDG, a group formed by American, European, and Japanese organizations in 1989, has expanded in recent years to further its attempts to harmonize pharmacopeial topics. The group began its initial expansion phase in 2022 and, after a successful pilot, named the Indian Pharmacopoeia Commission (IPC) its first new member in 2023.

Recently, PDG began the second expansion round, deciding to admit one entity during the second round. PDG said the decision built on recent experience and will ensure that any new candidate receives “appropriate support,” adding that it “carefully reviewed its available resources in light of its strategic priorities.”

PDG said selection of the Korean Pharmacopoeia was a consensus decision that “reflects the quality of the Korean Pharmacopoeia’s application and its alignment with the PDG’s mission to promote global harmonization of pharmacopeial standards.”

As a candidate participant, the Korean Pharmacopoeia will spend its first year observing PDG activities and meetings, then enter the active phase. For one year or more, the candidates actively take part in PDG activities and meetings. PDG requires candidates to submit comments and feedback, continue implementing its texts and actively integrate into harmonization work. Pharmacopeias that complete the active participation phase become members of PDG.

PDG is planning “fruitful discussions and harmonization work” with the Korean Pharmacopoeia in the coming months. The statement does not mention a potential third phase of PDG expansion. In the second phase, one year passed between PDG inviting other pharmacopeias to join and selecting the next candidate participant. The Korean Pharmacopoeia could become a full member in fall 2027.

Press Release

DRAP to study impact of Pakistan’s deregulation of non-essential medicine prices

The Drug Regulatory Authority of Pakistan (DRAP) has put out a tender for a study to assess the impact of deregulating the prices of non-essential medicines.

Pakistani officials deregulated the prices of products that are not on the National Essential Medicines List in February 2024. DRAP is planning to study the real-world consequences of the action. The agency wants individual consultants or research firms to run a national survey of current pricing trends, regional variations and the overall impact of deregulation on market dynamics and affordability.

The survey will focus on the 100 best-selling non-essential medicine brands. Researchers will collect prices of the medicines “from a representative sample,” DRAP said, and gather data from “various points across the pharmaceutical supply chain in Pakistan.” The survey data will inform a comparative analysis of pre- and post-deregulation prices to identify trends, variations and market behavior.

The agency wants the sampling strategy to cover all provinces and major urban and rural markets in the country. DRAP is working with the World Health Organization (WHO) on the project. WHO and DRAP will jointly review the proposed survey methodology and the draft report of the results. Joint feedback from the two organizations will inform the finalization of the report.

DRAP Tender

TGA finds counterfeit Botox amid seizure of 5.2M unlawfully imported products

Australian border officials have stopped two unrelated cases of counterfeit Botox that were bought from an overseas website.

The injectable botulinum toxin products were packaged to appear as genuine, branded Botox products, manufactured by Allergan, an AbbVie company. However, officials spotted inconsistencies on the product packaging, which features typographic errors including incorrect spacing, bolding and spelling mistakes. AbbVie confirmed the batch numbers on the packaging are not genuine.

Australia’s Therapeutic Goods Administration (TGA) said the products may pose a serious risk to health and should not be used. Consumers with a prescription can lawfully import prescription-only medicines for personal use into Australia. However, counterfeit products cannot be imported.

TGA published an alert about the counterfeit Botox the day before sharing details of its participation in Interpol's Operation Pangea XVII, a global initiative that targets the illegal trade in medical products. Australia recorded the largest seizures globally, discovering more than 5.2 million units of unlawfully imported therapeutic goods. The units included substandard and falsified products.

Psychostimulants such as modafinil and armodafinil were the most commonly seized group of products in Australia, followed by nicotine pouches and erectile dysfunction medicines. TGA, which assessed over 9,500 imports, said semaglutide products, Botox vials and ivermectin tablets were also found.

TGA Notice, More

India’s CDSCO moves cell and gene therapy trial applications to Sugam online portal

India’s Central Drugs Standard Control Organization (CDSCO) has begun using its online Sugam portal for applications to test cell and gene therapies in humans.

CDSCO stopped accepting offline applications on 10 July. The change applies to Phase I, II and III studies of cell and gene therapies. CDSCO framed the decision to move the filings to its online portal as part of a push to streamline regulatory submissions and procedures for the advanced therapies.

The agency directed organizations affected by the change to the user manual and video tutorial for filing clinical trial applications via the Sugam portal. Companies should submit applications “per the checklist in the developed modules,” CDSCO said.

Making Sugam use mandatory for cell and gene therapies continues the expansion of the portal. After launching Sugam in 2015, CDSCO began using the portal for clinical trials of recombinant DNA-derived drugs in 2018 and started accepting changes to study sites and investigators for biological trials this year.

CDSCO Notice

NPPA sets separate price for GSK paracetamol sachets after debate over advantages

India’s National Pharmaceutical Pricing Authority (NPPA) has set a separate price for GSK’s sachets of paracetamol and phenylephrine hydrochloride after a debate over the advantages of the product.

GSK attended NPPA meetings earlier this year to discuss the product. NPPA said the company “claimed advantages like faster solubility, faster disintegration hence better safety and efficacy, better AUC level, absorption in intestine, useful in patients who have difficulty in swallowing and claimed lower price compared to other companies.”

The information led NPPA’s Multidisciplinary Committee of Experts to propose a separate price for the sachets. NPPA recently formalized the proposal through an order that set the price at Rs. 6.96 per sachet ($0.08). GSK had requested a price of Rs. 27 per sachet.

NPPA Order

Other news

TGA updated its notice about the exemption of medical devices from a ban on the import, manufacture and use of three PFASs in Australia. The updated notice clarifies that the exemption applies to medicines and biologicals, including the primary and secondary packaging of the products. TGA has asked sponsors to contact it if their supply chains are disrupted by the ban. TGA Notice

TGA processed 6,258 good manufacturing practice (GMP) clearance extensions as part of its push to reduce its backlog of applications. The extensions apply to all mutual recognition agreement and non-sterile active pharmaceutical ingredient compliance verification GMP clearances that were expiring between 1 July 2025 and 30 June 2027. TGA Notice

Asia-Pacific Roundup: Korean Pharmacopoeia selected to participate in Pharmacopeial Discussion Group

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